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Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion (FOV2302)

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ClinicalTrials.gov Identifier: NCT00969293
Recruitment Status : Terminated
First Posted : September 1, 2009
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
Fovea Pharmaceuticals SA

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 1, 2009
Last Update Posted Date January 10, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Safety and tolerability parameters to determine MTD: 1. Systemic parameters: adverse events (AEs), coagulation parameters (APTT, ACT) 2. Ophthalmologic parameters: BCVA, OCT, ocular inflammation, IOP [ Time Frame: 3 months post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
Safety and tolerability parameters to determine MTD: 1. Systemic parameters: adverse events (AEs), coagulation parameters (APTT, ACT) 2. Ophthalmologic parameters: BCVA, OCT, ocular inflammation, IOP
Change History Complete list of historical versions of study NCT00969293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Assess the pharmacodynamics up to five dose levels of a single administration of FOV2302 (ecallantide) by longitudinal measurements of the percent change of the macula thickness versus baseline as measured by OCT [ Time Frame: 3 months post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
Assess the pharmacodynamics up to five dose levels of a single administration of FOV2302 (ecallantide) by longitudinal measurements of the percent change of the macula thickness versus baseline as measured by OCT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
Official Title  ICMJE An Open-label, Dose Escalating Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
Brief Summary The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.
Detailed Description

Occlusive retinal vascular disease is not uncommon. Central retinal vein occlusion (CRVO) is the second most common vision-impairing vascular disorder of the retina following diabetic retinopathy. Severe visual loss from CRVO is caused by a combination of retinal edema and neovascular proliferation and ischemia. Vascular endothelial factors as they stimulate angiogenesis and increase vascular permeability, are majors pathogenic factors in CRVO. Counteracting these neovascular effects provide significant therapeutic benefit to subjects suffering from this disorder. Macular edema in this condition results from a conjunction of several, as yet, partially unknown factors.

Macular edema may occur in diseases causing cumulative injury over many years, such as diabetic retinopathy, or as a result of more acute events, such as branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Central Retinal Vein Occlusion
Intervention  ICMJE Drug: FOV2302 (Ecallantide)

Single intravitreal injection into the relevant eye.

Five dose levels will be studied from 5 to 90µg and a maximum of 6 subjects will be included at each dose level.

Duration of Treatment: Single injection with 3 months follow-up.

Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 9, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2009)
30
Estimated Study Completion Date  ICMJE March 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recent onset (< 6 months), non-ischemic CRVO (defined as association of documented retinal hemorrhage in all 4 quadrants of the retina with dilated veins) in patients who have not received treatment for their condition (e.g., no periocular depot or intraocular treatment [including corticosteroid and anti-VEGF], systemic corticosteroids or laser nor hemodilution).
  • Retinal thickness measured by Stratus OCT > 250µm in the central subfield of study eye at baseline.
  • BCVA score (measured by the ETDRS chart between 5 letters (20/800 Snellen equivalent) and 65 letters (20/50) in the study eye at baseline.
  • Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.
  • Females of childbearing potential using adequate birth control at Day 0 until study completion.
  • Patient able (in the opinion of the investigator) and willing to return for all scheduled visits and assessments.
  • Ability to read, understand and willingness to provide informed consent.

Exclusion Criteria:

  • Rubeosis iridis or neovascular glaucoma at baseline.
  • Preretinal neovascularisation at baseline.
  • Ischemic CRVO, defined by more than 10 disc area of non-perfusion on fluorescein angiography at baseline.
  • Any grade of diabetic retinopathy.
  • Other eye condition that could contribute to macular edema or cause retinal vascular changes (including vitreomacular traction, uveitis and inflammatory disease, etc).
  • Patients who have received treatment for their condition (e.g., no periocular depot or intraocular treatment [including corticosteroid and anti-VEGF], systemic corticosteroids or laser nor hemodilution).
  • Ocular surgery (including cataract extraction, scleral buckle, etc.) and/or YAG capsulotomy within 3 months preceding treatment date or anticipated within the 3 months following treatment administration.
  • Poorly controlled ocular hypertension and/or glaucoma (IOP greater than 25 mmHg despite maximal therapy).
  • History of pars plana vitrectomy.
  • Aphakia or anterior chamber intraocular lens.
  • Presence of visible sclera thinning or ectasia.
  • Presence of substantial cataract or other media opacity that, in the opinion of the investigator, is likely to interfere with visualization of the fundus or completion of study measurements.
  • Any active ocular or peri-ocular infection (including conjunctivitis, chalazion or significant blepharitis).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00969293
Other Study ID Numbers  ICMJE FOV2302/CLIN/101/P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fovea Pharmaceuticals SA
Study Sponsor  ICMJE Fovea Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Alain Gaudric, MD Hopital Lariboisiere
PRS Account Fovea Pharmaceuticals SA
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP